EP3544614B1 - ORAL TREATMENT BASED ON TESTOSTERONE UNDECANOATE - Google Patents

ORAL TREATMENT BASED ON TESTOSTERONE UNDECANOATE

Info

Publication number
EP3544614B1
EP3544614B1 EP17874365.4A EP17874365A EP3544614B1 EP 3544614 B1 EP3544614 B1 EP 3544614B1 EP 17874365 A EP17874365 A EP 17874365A EP 3544614 B1 EP3544614 B1 EP 3544614B1
Authority
EP
European Patent Office
Prior art keywords
dosing regimen
testosterone
dose
method comprises
fixed dose
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP17874365.4A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3544614A4 (en
EP3544614A1 (en
Inventor
Nachiappan Chidambaram
Satish Kumar Nachaegari
Mahesh V. Patel
Kilyoung Kim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lipocine Inc
Original Assignee
Lipocine Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lipocine Inc filed Critical Lipocine Inc
Publication of EP3544614A1 publication Critical patent/EP3544614A1/en
Publication of EP3544614A4 publication Critical patent/EP3544614A4/en
Application granted granted Critical
Publication of EP3544614B1 publication Critical patent/EP3544614B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP17874365.4A 2016-11-28 2017-11-28 ORAL TREATMENT BASED ON TESTOSTERONE UNDECANOATE Active EP3544614B1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201662427103P 2016-11-28 2016-11-28
US201662428336P 2016-11-30 2016-11-30
US201762442612P 2017-01-05 2017-01-05
PCT/US2017/063535 WO2018098501A1 (en) 2016-11-28 2017-11-28 Oral testosterone undecanoate therapy

Publications (3)

Publication Number Publication Date
EP3544614A1 EP3544614A1 (en) 2019-10-02
EP3544614A4 EP3544614A4 (en) 2020-08-05
EP3544614B1 true EP3544614B1 (en) 2025-12-31

Family

ID=62193473

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17874365.4A Active EP3544614B1 (en) 2016-11-28 2017-11-28 ORAL TREATMENT BASED ON TESTOSTERONE UNDECANOATE

Country Status (5)

Country Link
US (3) US11559530B2 (cg-RX-API-DMAC7.html)
EP (1) EP3544614B1 (cg-RX-API-DMAC7.html)
JP (1) JP2020503269A (cg-RX-API-DMAC7.html)
CA (1) CA3078723A1 (cg-RX-API-DMAC7.html)
WO (1) WO2018098501A1 (cg-RX-API-DMAC7.html)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2006236564B2 (en) 2005-04-15 2011-02-17 Besins Healthcare Luxembourg S.A.R.L. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
CA2822435C (en) 2009-12-31 2018-09-11 Differential Drug Development Associates, Llc Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
US20180153904A1 (en) * 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
ES2907284T3 (es) 2013-03-15 2022-04-22 Marius Pharmaceuticals Llc Formulaciones de emulsión
WO2016205423A2 (en) 2015-06-15 2016-12-22 Lipocine Inc. Composition and method for oral delivery of androgen prodrugs
US11559530B2 (en) * 2016-11-28 2023-01-24 Lipocine Inc. Oral testosterone undecanoate therapy
JP2021531348A (ja) 2018-07-20 2021-11-18 リポシン，インク． 肝臓病
US12403146B2 (en) 2019-10-30 2025-09-02 Marius Pharmaceuticals, Inc. Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
US11464735B2 (en) 2020-09-25 2022-10-11 Lipocine Inc. Fixed dose oral testosterone undecanoate compositions and use thereof

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US11559530B2 (en) 2023-01-24
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WO2018098501A1 (en) 2018-05-31
JP2020503269A (ja) 2020-01-30
US20180333422A1 (en) 2018-11-22
CA3078723A1 (en) 2018-05-31
US20190240236A1 (en) 2019-08-08

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